Compositions, Kits, and Methods for the Treatment of Conditions Associated with Elevated Cholesterol Levels

Abstract

Disclosed herein are methods of treating a condition associated with elevated cholesterol levels are provided, comprising administering to a mammal in need of such treatment a safe and effective amount of a cholesterol biosynthesis inhibitor and a soluble fiber. Further disclosed herein are kits comprising a first composition comprising a cholesterol biosynthesis inhibitor selected from the group consisting of HMG CoA reductase inhibitors, HMG CoA synthase inhibitors, and mixtures thereof; and a second composition comprising a soluble fiber. Even further described are compositions comprising a cholesterol biosynthesis inhibitor selected from the group consisting of HMG CoA reductase inhibitors, HMG CoA synthase inhibitors, and mixtures thereof; and a soluble fiber.

1 . A method of lowering the total cholesterol level in a human comprising administering to a human
 a. at least one unit dose of cholesterol biosynthesis inhibitor selected from the group consisting of HMG CoA reductase inhibitors, HMG CoA synthase inhibitors, and mixtures thereof;   b. a first unit dose of soluble fiber;   c. a second unit dose of soluble fiber; and   d. a third unit dose of soluble fiber;   wherein the total cholesterol level is lowered.   
     
     
         2 . The method according to  claim 1  wherein the cholesterol biosynthesis inhibitor is an HMG CoA reductase inhibitor selected from the group consisting of lovastatin, pravastatin, simvastatin, atorvastatin, and mixtures thereof. 
     
     
         3 . The method according to  claim 1  wherein the unit dose of cholesterol biosynthesis inhibitor comprises from 5 milligrams to 80 milligrams of cholesterol biosynthesis inhibitor. 
     
     
         4 . The method according to  claim 3  wherein the unit dose of cholesterol biosynthesis inhibitor comprises from 10 milligrams to 20 milligrams of cholesterol biosynthesis inhibitor. 
     
     
         5 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose are selected from the group consisting of fructooligosaccharides, psyllium, oat fiber, and combinations thereof. 
     
     
         6 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber comprise psyllium. 
     
     
         7 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber comprise at least one gram of soluble fiber. 
     
     
         8 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber comprise at least two grams of soluble fiber. 
     
     
         9 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber comprise at least three grams of soluble fiber. 
     
     
         10 . The method according to  claim 1  wherein the unit dose of cholesterol biosynthesis inhibitor, the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber are administered concurrently. 
     
     
         11 . The method according to  claim 1  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber are administered two or three times daily. 
     
     
         12 . The method according to  claim 11  wherein the first unit dose of soluble fiber, the second unit dose of soluble fiber, and the third unit dose of soluble fiber are administered with meals and the unit dose of cholesterol biosynthesis inhibitor is administered once daily. 
     
     
         13 . The method according to  claim 12  wherein the unit dose of cholesterol biosynthesis inhibitor and the third unit dose of soluble fiber are administered concurrently in the evening hours. 
     
     
         14 . The method according to  claim 1  wherein the cholesterol is reduced by at least 25%. 
     
     
         15 . The method according to  claim 1  wherein the cholesterol is reduced at least about 30%. 
     
     
         16 . The method according to  claim 1  wherein the administration occurs for at least 14 days. 
     
     
         17 . The method according to  claim 1  wherein the administration occurs for at least 28 days. 
     
     
         18 . The method according to  claim 1  wherein the unit dose of cholesterol biosynthesis inhibitor and the third unit dose of soluble fiber are a single composition. 
     
     
         19 . A method of lowering the total cholesterol level in a human comprising administering to a human
 a. from 5 milligrams to 80 milligrams of a HMG CoA reductase inhibitor selected from the group consisting of lovastatin, pravastatin, simvastatin, atorvastatin, and mixtures thereof, wherein the HMG CoA reductase inhibitor is administered one time daily in the evening;   b. a first unit dose of psyllium comprising from 1 gram to 3 grams of psyllium administered at a first time;   c. a second unit dose of psyllium comprising from 1 gram to 3 grams of psyllium administered at a second time; and   d. a third unit dose of psyllium comprising from 1 gram to 3 grams of psyllium wherein the third unit dose of psyllium is administered concurrently with the HMG CoA reductase inhibitor during the evening hours; and   wherein the total cholesterol level is lowered by at least 25%.   
     
     
         20 . The method of  claim 19  comprising from about 10 milligrams to about 20 milligrams of the HMG CoA reductase inhibitor, 3 grams of a first unit dose of psyllium, 3 grams of a second unit dose of psyllium, and 3 grams of a third unit dose of psyllium.